Effects of Low-frequency Electrical Stimulation in Sympathetic Nerve Activity and Peripheral Vasoconstriction in Patients With Advanced HF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Functional assessment
研究概览
简要总结
The purpose of this study is to verify the effects of low frequency functional electrical stimulation in heart failure patients hospitalized for treatment of the syndrome.
详细描述
The aim of this study is to assess the effects of low frequency functional electrical stimulation on control autonomic and peripheral function in heart failure patients hospitalized for treatment of the syndrome. A randomized clinical trial with 30 advanced heart failure patients will be randomly assigned to functional electrical stimulation (Functional EE, n= 15) e 2) sensory electrical stimulation (Sensory EE, n=15). The functional electrical stimulation will be applied in the rectus femoris, and gastrocnemius, with frequency of 10 Hz, pulse duration of 150 ms, stimulation time (time on) of 20 seconds, resting time (time off) of 20 seconds and intensity according to the discomfort threshold of the patient , checked every day until achieve a maximum of 70mA. The session will last 60 minuts. It will be held every weekday for a period of 10 days. The effects of interventions on functional capacity, autonomic control, peripheral function, peripheral muscle strength and quality of life will be analyzed at baseline and at the end of the protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced heart failure,
- •Class Functional IV, according to the criteria of New York Heart Association (NYHA),
- •Aged over 18 years,
- •Etiology hypertensive, ischemic, idiopathic or chagas disease,
- •Left ventricular ejection fraction ≤ 30%.
排除标准
- •Patients with hypertension lung disease and oxygen-dependent,
- •Neurological and neuromuscular disease that presenting paresthesia or plegia of the lower limbs,
- •Insulin-dependent diabetes mellitus (type I),
- •Peripheral arterial occlusive disease,
- •Peripheral neuropathy,
- •Use of pacemaker or implantable cardiodefibrillator.
研究组 & 干预措施
Functional Electrical Stimulation
Functional Electrical Stimulation for 10 days
干预措施: Functional electrical stimulation (Other)
Control Electrical Stimulation
Control Electrical Stimulation for 10 days
干预措施: Placebo electrical stimulation (Other)
结局指标
主要结局
Functional assessment
时间窗: 10 days
To assess the effects of the functional electrical stimulation in patients with advanced heart failure.
次要结局
- Peripheral muscle strength(10 days)
- Peripheral function(10 days)
研究者
Raphaela Vilar Ramalho Groehs
PhD student
University of Sao Paulo General Hospital